History and development

The Department’s history dates to 1987, when high-dose chemotherapy with autologous stem-cell support was introduced at Radiumhospitalet for patients with lymphoma. At that time, the Oslo hospitals operated separate apheresis and stem-cell laboratories: Radiumhospitalet and Ullevål supported autologous transplantation, while Rikshospitalet also collected cells for allogeneic transplantation from related donors and unrelated donors recruited through the Norwegian Bone Marrow Donor Registry.

Between 2005 and 2010 these activities were consolidated at Radiumhospitalet. In 2009, the laboratory teams from Radiumhospitalet, Rikshospitalet and Ullevål moved into the current GMP facility, creating a unified professional environment for cell-therapy laboratory services and transplantation support. The transplantation programme is accredited by JACIE for adult and paediatric autologous and allogeneic transplantation, immune-effector-cell administration, collection of bone marrow and apheresis products, and minimally manipulated cell processing. 

From the late 1990s, the Department increasingly expanded into cell-based immunotherapy and ATMP manufacturing. It developed platforms for dendritic-cell vaccines and genetically modified T-cell therapies, including CAR-T and TCR-T products, and established the competence and quality systems required for academic and industry-sponsored clinical studies. The Department holds a manufacturing authorisation from the Norwegian Medical Products Agency (DMP), covering authorised investigational medicinal products manufactured at the facility, including dendritic-cell products, decidual stromal cells, Pseudovax and the hypoimmune pancreatic islet-cell product UP421.

Today, the Department operates one of Norway’s most extensive hospital-based cell-therapy infrastructures. Its facilities include a dedicated apheresis room, seven Grade B ex vivo rooms, a general production room, a dedicated Grade B BSL-2 laboratory, Grade D quality-control areas, cryopreservation and long-term storage. These facilities support transplantation services, routine cell processing and the development and GMP manufacture of advanced cell and gene therapies.